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FDA PMA

Immunohistochemistry Assay, Antibody, MET

Número do PMA: P240037 · 2025-07-11

RequerenteVentana Medical Systems, Inc. (Roche Tissue Diagnostics)
Data da decisão2025-07-11
Número PMAP240037
Código do produtoSER
Classe do DispositivoClasse 3
Especialidade MédicaH
Número da Regulamentação21 CFR 8
Comité consultivoPA

Resumo do dispositivo

Immunohistochemistry Assay, Antibody, MET is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics). It received FDA 510(k) clearance on 2025-07-11. The device is classified under product code SER. It was reviewed by the PA advisory panel.

Perguntas frequentes

What is the Immunohistochemistry Assay, Antibody, MET?

Immunohistochemistry Assay, Antibody, MET is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics).

When did Immunohistochemistry Assay, Antibody, MET receive FDA 510(k) clearance?

The clearance date for Immunohistochemistry Assay, Antibody, MET can be found in the official FDA records.

Who is the listed applicant for Immunohistochemistry Assay, Antibody, MET?

The FDA 510(k) record lists Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Immunohistochemistry Assay, Antibody, MET?

The FDA product code for Immunohistochemistry Assay, Antibody, MET is SER.

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Fonte oficial

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